Regulatory Affairs Analyst - San Francisco, United States - University of California San Francisco

University of California San Francisco

Verified Company

San Francisco, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

The analyst works independently, under the direction of the Regulatory Affairs Manager, to review cooperative and industry-sponsored protocols, revise local informed consents (ICFs), and submit review packets (protocols, ICFs, and other required documents) to the UCSF IRB and external IRBs.

- Day to day tasks include:

Assist Regulatory Affairs Manager with work request triage prior to weekly assignment distribution.
Accept regulatory assignments each week as assigned by the Regulatory Affairs Manager.
Volunteer for work assignments that are deemed time sensitive and are outside of the weekly assignment schedule.
Revise ICFs for current trials on sponsor templates by incorporating HDFCCC template language.
Collaborate with study submitters to receive Radiation Safety Committee (RSC) approval.
Monitor, triage and address stipulations received from IRB by communicating with study submitters, sponsors and the IRB, to finalize the submission and gain approval. Will communicate needs to the Regulatory Affairs Manager when communication has not been received from the appropriate party within one week of request.
Review ICF changes for studies relying on external IRB to ensure required institutional language is included and edit the ICFs when needed to gain approval.
Deliver prompt and clear communications with counterparts in the regulatory unit, study teams, sponsors, IRBs, and various constituent groups within the Helen Diller Family Comprehensive Cancer Center (HDFCCC).

For roles covered by a bargaining unit agreement, there will be specific rules about where a new hire would be placed on the range.

Department Description

This position is housed in the Clinical Research Support Office (CRSO), a centralized clinical trial management office in the UCSF Helen Diller Family Comprehensive Cancer Center (HDFCCC), which provides project management and clinical research coordinator staff, and regulatory services for oncology related clinical trials.
The HDFCCC is one of only two cancer centers in the Bay Area to hold the prestigious designation of "comprehensive" from the National Cancer Institute (NCI).

We integrate the work of researchers and clinicians dedicated to four fundamental pursuits:

laboratory research into the causes of cancer progression; clinical research to translate new knowledge into viable treatments; compassionate, state-of-the-art patient care; and population research that can lead to improvements in prevention, early detection, and quality-of-life for those living with cancer.

The twin pillars of precision medicine and precision population health guide research and treatment at HDFCCC.

Required Qualifications

Bachelor's degree in related area and / or equivalent experience / training.
Minimum of one year of related experience.
Ability to solve problems, issues; listen, interpret and confirm understanding of others' communications; and be objective.
Effective, efficient and tactful oral and written communication skills.
Time management skills and the flexibility to accommodate changing priorities in unit.
Ability to work in a team oriented setting, to prioritize work, and to follow through on routine assignments with mínimal direction.
Proficiency with computers, including the ability to operate personal computer software with sophisticated retrieval, storage, and merging capabilities.
Excellent customer service skills, pleasant, helpful and patient.
Independence, planning and decisionmaking abilities to complete assigned duties.
Strong organizational skills, the ability to multitask, and work with frequent interruptions.

Preferred Qualifications

Relevant compliance certification (if applicable) preferred (RAC, SoCRA, CCRP, PMP, etc).
Knowledge of relevant Federal and State regulations, and policies.

About UCSF

The University of California, San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduatelevel education in the life sciences and health professions, and excellence in patient care. It is the only campus in the 10campus UC system dedicated exclusively to the health sciences. We bring together the world's leading experts in nearly every area of health. We are home to five Nobel laureates who have advanced the understanding of cancer, neurodegenerative diseases, aging and stem cells.

Pride Values

In addition to our PRIDE values, UCSF is committed to equity both in how we deliver care as well as our workforce. We are committed to building a broadly diverse community, nurturing a culture that is welcoming and supportive, and engaging diverse ideas for the provision of culturally competent education, discovery, and patient care. Additional information about UCSF is available at
Join us to find a rewarding career contributing to improving healthcare worldwide.

Equal Employment Opportunity